Consortium Strategizing to Bring More Studies to Lombardia

By Deborah Borfitz

July 21, 2008 | Many nations lack the infrastructure and expertise to expand clinical research and trials. Now there’s a single place to turn to for help with all the critical, on-the-ground support services to accomplish the task.

Three Massachusetts firms – clinical trial electronic data collection company Phase Forward, clinical trials enrollment management specialist BBK Worldwide, and life sciences information technology (IT) and regulatory compliance consultant Court Square Group – teamed up with Tufts Medical Center’s statewide Institute for Clinical Research and Health Policy Studies (ICRHPS) last fall to assist Italy’s Lombardia region grow its clinical research enterprise. The group, which calls itself the Clinical Research Consortium of Massachusetts (CRCM), has since attracted the attention of government and life science leaders in at least five other countries.

The consortium is the product of an economic development initiative of the Massachusetts Office of International Trade and Investment (MOITI) to link the state with Lombardia, one of 20 regions in Italy and hub for half of the country’s biotechnology companies, says Keith Parent, CEO of Springfield-based Court Square Group. MOITI successfully competed against other states, including California and North Carolina, for the partnering opportunity. In conjunction with government leaders from Lombardia, MOITI then tapped the four CRCM organizations out of an initial field of 12 to make knowledge and technology transfer happen.

Currently, Lombardia accounts for only about 2 percent of Europe’s clinical trial business, says Parent. Germany, the U.K., and the Scandinavian countries all do considerably more. But given the right infrastructure, the region’s potential could be unleashed.

Italy already has a strong academic medical tradition and seasoned investigators who helped revolutionized the treatment of breast cancer and acute myocardial infarctions, notes Harry Selker, MD, MSPH, director of the ICRHPS as well as the Tufts Clinical and Translational Science Institute.

Rather than simply export a “solution,” CRCM paid a site visit to Lombardia to conduct a needs assessment and then came home to begin crafting a major five-year program for a Lombardia Clinical and Translational Research Institute. Selker says it “echoes” a movement led by the National Institutes of Health to more directly convert basic research into real therapies for real patients and is patterned after the Tufts Clinical and Translational Science Institute.

The plan, an outline of which was enthusiastically received by the Lombardia Ministry of Health last month, has three key features, says Selker. These include outreach (marketing and regulatory compliance); a study design and data resource center to meet clinical trials’ logistics and IT needs from design to execution; and an academic arm providing training for investigators and site personnel and, ultimately, development of a masters and doctoral degree program in clinical research. Tufts University Sackler School of Graduate Biomedical Science introduced the first such master’s and doctoral program in 1999.

Members of CRCM will each have distinct responsibilities, says Selker, and personnel and faculty may be exchanged with their counterparts in Lombardia. In addition, Tufts will involve its long-time international affiliate, the Vienna School of Clinical Research. The other CRCM members also have a presence and extensive clinical trial experience throughout Europe.

Academic support for investigator-initiated research is important, says Selker, because in its absence only molecules owned by industry get tested. Recently, the focus of academic medical centers has been expanding to include more large, late-stage clinical trials.

Court Square Group’s support services to Lombardia might include infrastructure qualification, implementation and application integration, and Good Clinical Practice services to fully support the proposed infrastructure improvements and best practice usage, says Parent.

The CRCM’s goal is to hand off a full, polished proposal to Lombardia officials in September. The Ministry of Health would like to be doing 6 to 8 percent of European trials by 2015. Meanwhile, the group has seen interest from Chile, Mexico, Brazil, France, and Spain about building clinical research centers of excellence in those countries.

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